Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (‘the applicant’) shall submit an application to the F2competent authority.

The applicant shall submit all data that the F2competent authority requires to assess technical equivalence.

The F2competent authority shall inform the applicant of the F3appropriate fees and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

After giving the applicant the opportunity to submit comments, the F2competent authority shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it F4... to the applicant.

Where, in the opinion of the F2competent authority, additional information is necessary to carry out the assessment of technical equivalence, the F2competent authority shall ask the applicant to submit such information within a time limit specified by the F2competent authority. The F2competent authority shall reject the application if the applicant fails to submit the additional information within the specified time limit. The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received. The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances.

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An appeal may be brought, in accordance with Article 77, against decisions of the F2competent authority under paragraphs 3, 4 and 5 of this Article.

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